The U.S. Food and Drug Administration approved Amgen Inc.'s Repatha as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with cardiovascular disease.
The agency gave the approval following a priority review of Amgen's supplemental biologics license application for Repatha.
Repatha's cardiovascular outcomes phase 3 trial showed that the drug reduced risk of heart attack by 27%, risk of stroke by 21% and risk of coronary revascularization by 22%.
The FDA also approved Repatha to be used as an adjunct to diet, alone or in combination with other lipid-lowering therapies, such as statins, to treat adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol.
Repatha is approved in more than 50 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the EU. Applications in other countries are pending.
